Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS
Status:
Recruiting
Trial end date:
2027-05-01
Target enrollment:
Participant gender:
Summary
Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis
(RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another
anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the
treatment of RMS. An advantage of rituximab is a considerably lower price. Therefore we will
start a study aimed at demonstrating non-inferiority of rituximab compared to ocrelizumab in
RMS. If non-inferiority of rituximab can be shown, important reductions in the cost of
treatment of RMS will be possible, without loss of efficacy.
Objective: Evaluating the efficacy and safety of ritixumab compared to ocrelizumab in the
treatmens of RMS.
Study design: Randomized double blind multi-centre non-inferiority study of rituximab
compared to ocrelizumab in 200 patients with RMS. The trial duration will be 30 months
Study population: The study population consists of 200 adult RMS patiens with an indication
to start anti-CD20 monoclonal antibody treatment.
Intervention: Patients will be randomized 1:1 into the standard group (ocrelizumab treatment)
or the experimental group (rituximab treatment).
Main study parameters: To conclude non-inferiority of rituximab there will be one primary
endpoint: the proportion of patients free of inflammatory disease activity (defined as: new
or enlarged T2 lesions) between week 24 (M6) and week 96 (M24) of treatment in each arm.
Secondary trial endpoints are presence and number of clinical relapses,T2 and contrast
enhancing lesion volumes, brain volume and brain volume changes, disease progression (defined
as clinically relevant change on any of the measures: EDSS, T25FW, 9HPT, SDMT), biochemical
parameters such as lipidomics and neurofilament light (NfL), immunological parameters, safety
as measured by the number of (serious) adverse events ((S)AE), quality of life (EQ-5D-L) and
treatment satisfaction (TSQM) and patient reported measures of MS impact (MSIS-29) and
well-being (questionnaire on physical complaints)
Nature and extent of the burden and risk: Patients included in this study will be treated and
monitored by MRI, clinical tests and laboratory tests according to existing protocols and
will not be exposed to extra or unknown risks. They will have extra annual questionnaires and
larger blood samples at some time points. There is extensive experience with both rituximab
and ocrelizumab as efficacious and safe treatments of RMS.